BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE W/LOCK SCREW

    MDR report key: 1930691 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01332
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO THE SCREW OF THE ARTICULAR SURFACE LOOSENING AND BACKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE W/LOCK SCREW KNEE PROSTHESIS JWH ZIMMER, INC. 78881100

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention